Senior Medical Director

Role Overview

• Lead the clinical strategy and execution for the HCM program, including Phase 3 trial design, implementation, and oversight.
• Serve as Medical Monitor for assigned clinical studies, ensuring patient safety, data integrity, and protocol adherence across all global sites.
• Provide medical and scientific leadership to cross-functional study teams, including Clinical Operations, Regulatory, Biostatistics, and Data Management.
• Partner with Regulatory Affairs to support global health authority interactions, including IND/CTA submissions, briefing documents, and responses to regulatory inquiries.
• Collaborate with the Chief Medical Officer and senior leadership to define and execute the overall clinical development plan and ensure alignment with corporate strategy.
• Lead clinical data interpretation, analysis review, and support preparation of clinical study reports, manuscripts, and scientific presentations.
• Engage with external experts, investigators, and key opinion leaders (KOLs) to inform program strategy and strengthen Braveheart Bio’s scientific network in cardiology and HCM.
• Contribute to development of risk mitigation strategies, protocol amendments, and study governance processes.
• Support internal decision boards and cross-functional portfolio planning as the clinical subject matter expert for the HCM program.

Requirements

• M.D. or D.O. degree (board certification in cardiology or related specialty preferred)
• Minimum of 6 years of clinical development experience in the biopharmaceutical industry, including leadership of Phase 3 trials
• Proven track record of clinical trial design, implementation, and medical oversight within cardiology or a closely related therapeutic area
• Experience interfacing with global regulatory authorities and contributing to pivotal submission packages
• Demonstrated ability to synthesize complex clinical and scientific data and communicate clearly to internal and external stakeholders
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude
• Experience specifically in Hypertrophic Cardiomyopathy (HCM) or broader cardiomyopathy/cardiovascular disorders is strongly preferred
• Prior experience as a Global Clinical Lead or equivalent senior role overseeing multicenter, global late-stage programs
• Demonstrated success fostering cross-functional collaborations and managing external partnerships or CROs
• Knowledge of biomarkers, imaging endpoints, and patient-reported outcomes relevant to cardiovascular diseases
• Strong familiarity with regulatory frameworks for pivotal trials (FDA, EMA, PMDA) and BLA/NDA/MAA filings
• Strategic thinker with the ability to balance scientific rigor and pragmatic execution in a startup setting